Cleared Traditional

K091814 - FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM

Also marketed or referenced as:
TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE

K091814 is an FDA 510(k) clearance for FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESS..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K091814 · Taidoc Technology Corporation · Chemistry device
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Nov 2009
Decision
155d
Days
Class 2
Risk

K091814 is an FDA 510(k) clearance for the FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 20, 2009 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K091814

510(k) Number K091814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date November 20, 2009
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K091814.
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
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K083570 · Taidoc Technology Corporation · Mar 2009
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
K082482 · Taidoc Technology Corporation · Jan 2009